Tiziana Life Sciences, Ltd. (TLSA) announced that its open-label clinical study of intranasal foralumab in non-active secondary progressive multiple sclerosis has now been peer-reviewed and published, underscoring the therapy's potential to address progression in patients who continue to worsen despite prior treatments.
Non-active secondary progressive multiple sclerosis (na-SPMS) is a challenging stage of multiple sclerosis in which patients experience steady neurological decline without relapses. With limited treatment options available, slowing progression remains a major unmet need.
The newly published study, appearing in Neurology Neuroimmunology & Neuroinflammation, evaluated intranasal foralumab- a fully human anti-CD3 monoclonal antibody- in 10 patients with na-SPMS who had continued to progress despite earlier B-cell- directed therapies.The publication confirms the positive clinical and biomarker findings that the company first reported in May 2025.
Study Overview
The open-label trial assessed whether intranasal delivery of foralumab could modulate immune activity in a way that slows MS progression. According to the published data, the treatment demonstrated:
•Improvement in clinical symptoms in several patients
•Favorable biomarker shifts consistent with reduced inflammation
•A well-tolerated safety profile, with no major safety concerns reported
The study titled "Nasal Foralumab for the Treatment of Progression Independent of Relapses in Patients with Non-active Secondary Progressive Multiple Sclerosis" reflects its focus on a patient population that typically sees few therapeutic advances.
Why Intranasal Delivery Matters
Foralumab's intranasal route is designed to engage the immune system through mucosal pathways, potentially offering a safer and more targeted approach than systemic immunosuppression. Tiziana has long positioned this mechanism as a differentiator in autoimmune disease treatment.
Next Steps for the Program
With peer-reviewed validation now in place, Tiziana is expected to continue advancing intranasal foralumab through additional clinical development. The company has previously highlighted its intention to explore broader applications of the therapy across neuroinflammatory and autoimmune conditions.
Tiziana is advancing intranasal foralumab in an ongoing randomized, double-blind, placebo-controlled Phase 2 trial in na-SPMS, with top-line data expected in the first half of 2026.
TLSA has traded between $0.63 and $2.60 over the past year. The stock closed yesterday's trading at $1.58, down 5.95% and rose in the overnight trading to $1.69, up 6.96%.
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